Treatment With Rosuvastatin Versus Switching PI (Protease Inhibitor) in Patients HIV With High Cholesterol Levels

NCT01935674 | Completed Phase 4 Results DMC

• 1 other identifier: SOS
• Study Type: interventional
• Target: 43
• Locations: 1 country
• Sites: 1

Brief Summary

To compare the effect of rosuvastatin to protease inhibitor switching on fasting total cholesterol over 12 weeks.

Conditions

HIV; Hypercholesterolaemia

Keywords

Hypercholesterolaemia; HIV; Rosuvastatin; Protease inhibitor switching

Outcome Measures

Primary Outcomes (1)

• Percentage Change From Baseline in Total Cholesterol at 12 Weeks.

  The outcome was defined as the percentage change in fasting total cholesterol from baseline (week 0) to week 12. Fasting blood samples were collected after a 12-hour fast, and total cholesterol was measured in mmol/L. The percentage change was calculated for each participant and compared between the rosuvastatin and PI/r switch groups using an intention-to-treat analysis.

  12 weeks from baseline (week 0 to week 12)

Secondary Outcomes (7)

• Total Cholesterol Through Week 12

  12 weeks

• Safety Parameters (HIV Viral Load, Clinical Adverse Events, Serious Adverse Events, Laboratory Adverse Events, Modifications to Antiretroviral Therapy)

  12 weeks

• Quality of Life (SF-12)

  12 weeks

• Fasting LDL Cholesterol (Estimated With Friedewald Equation Unless Triglycerides >400mg/dL, in Which Case LDL-C Would be Measured Directly), HDL Cholesterol, Total : HDL Cholesterol Ratio, LDL Particles Sizes, Triglycerides

  12 weeks

• Fasting Glucose and Insulin.

  12 weeks

Study Arms (2)

Switch ritonavir-boosted PI

EXPERIMENTAL

Switch their existing ritonavir-boosted PI to another potent ART drug with lesser effects on serum cholesterol selected by the investigator.

Drug: Switch ritonavir-boosted PI

Continue ritonavir-boosted PI+Rosuvastatin

EXPERIMENTAL

Continue ritonavir-boosted PI-based ART and commence rosuvastatin 10 mg daily (5 mg daily in Asian participants).

Drug: Continue Ritonavir-boosted PI+Rosuvastatin

Interventions

Switch ritonavir-boosted PI DRUG

Switch their existing ritonavir-boosted PI to another potent ART drug with lesser effects on serum cholesterol selected by the investigator.

Switch ritonavir-boosted PI

Continue Ritonavir-boosted PI+Rosuvastatin DRUG

Continue ritonavir-boosted PI-based ART and commence rosuvastatin 10 mg daily (5 mg daily in Asian participants).

Continue ritonavir-boosted PI+Rosuvastatin

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• HIV-positive status
• Adults (≥18 years of age)
• Stable and well-tolerated combination ART including a ritonavir-boosted protease inhibitor for the previous 6 months
• HIV RNA \<50 copies/mL for at least the preceding 3 months
• Fasting total cholesterol ≥5.5 mmol/L (\>213 mg/dL)
• Framingham risk score ≥8% at 10 years OR diabetes mellitus OR a family history of premature coronary artery disease in a first-degree relative
• Provision of written, informed consent

You may not qualify if:

• Any statin in the previous 12 weeks
• Previous statin-induced myopathy or hepatitis
• History of coronary artery disease, stroke or any other indication for the use of statin therapy (hyperlipidaemia: genetic, secondary or idiopathic)
• Concurrent use of:
• oral corticosteroids use other than for replacement therapy (i.e. prednisolone 5-7.5 mg, hydrocortisone 20-30 mg, cortisone acetate 25-37.5 mg daily)
• other immunosuppressive or immunomodulating drugs
• Contraindication to rosuvastatin therapy:
• liver transaminases \>5 times the upper normal limit
• creatinine clearance \<30 mL/min
• known myopathy
• current fibrate therapy
• known resistance to one or more "backbone" ART drugs
• No potent switch ART drug available to replace the current ritonavir-boosted protease inhibitor
• Known intolerance to rosuvastatin or the proposed switch ART drug
• Women attempting or likely to become pregnant, or who are pregnant or breast-feeding

Sponsors & Collaborators

• Juan A. Arnaiz: lead

Study Sites (1)

Hospital Clinic of Barcelona

Barcelona, 08036, Spain

Location

Related Links

• Rosuvastatin vs. protease inhibitor switching for hypercholesterolaemia: a randomized trial

MeSH Terms

Conditions

Hypercholesterolemia

Condition Hierarchy (Ancestors)

Hyperlipidemias; Dyslipidemias; Lipid Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Limitations and Caveats

Small, short-duration study with a homogeneous population. Not powered for clinical outcomes. Results may not generalize broadly.

Results Point of Contact

• Title: Dr. Esteban Martínez
• Organization: Hospital Clinic of Barcelona

estebanm@clinic.cat

+34 93 227 54 00

Study Officials

• Esteban Martinez, MD

  Hospital Clinic of Barcelona

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Project manager

Study Record Dates

• First Submitted: March 19, 2013
• First Posted: September 5, 2013
• Study Start: September 1, 2013
• Primary Completion: September 1, 2014
• Study Completion: September 1, 2014
• Last Updated: July 16, 2025
• Results First Posted: July 16, 2025

Record last verified: 2025-06

Locations

ES (1)